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Intraoperative MRI and 5-ALA Guidance to Improve the Extent of Resection in Brain Tumor Surgery (IMAGER)

Primary Purpose

Primary Malignant Neoplasm of Nervous System, Glioma, Glioblastoma

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Interventional arm
Control arm
Sponsored by
Johann Wolfgang Goethe University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Malignant Neoplasm of Nervous System focused on measuring primary brain tumor, malignant glioma, intraoperative MRI, 5-ALA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adult patient (> 18 years) able to give informed consent
  • primary supratentorial intra-axial brain tumor exhibiting contrast enhancement suspected to be malignant glioma
  • tumor must be deemed completely resectable by neurosurgeon
  • diagnostic MRI

Exclusion Criteria:

  • patient unable or unwilling to give informed consent
  • infratentorial tumor location
  • tumor location in or near eloquent areas
  • multifocal tumor
  • existance of contraindications to undergo MRI examination
  • previous surgical treatment for an intraaxial brain tumor

Sites / Locations

  • Klinik für Neurochirurgie Johann Wolfgang Goethe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Control arm

Interventional arm

Arm Description

5-ALA fluorescence guided surgery in patients with contrast enhancing tumors.

5-ALA fluorescence guided surgery with the additional use of an intraoperative MRI for resection control in patients with contrast enhancing tumors.

Outcomes

Primary Outcome Measures

Extent of Resection
The primary efficacy endpoint is the rate of complete resections according to early postoperative MRI.

Secondary Outcome Measures

Volumetric extent of resection
Secondary endpoint is the volumetric extent of resection as determined by direct comparison of preoperative and early postoperative tumor volumes.
PFS 6
Secondary endpoint is the rate of subjects with progression-free survival (PFS) 6 months after tumor resection
PFS 12
Secondary endpoint is the rate of subjects with progression-free survival (PFS) 12 months after tumor resection
Quality of life
Patient quality of life at 6 and 12 months following surgery is a secondary endpoint

Full Information

First Posted
February 22, 2013
Last Updated
February 25, 2013
Sponsor
Johann Wolfgang Goethe University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01798771
Brief Title
Intraoperative MRI and 5-ALA Guidance to Improve the Extent of Resection in Brain Tumor Surgery
Acronym
IMAGER
Official Title
Intraoperative MRI and 5-ALA Guidance to Improve the Extent of Resection in Brain Tumor Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johann Wolfgang Goethe University Hospital

4. Oversight

5. Study Description

Brief Summary
The investigators hypothesize that the rate of radiologically complete resections of contrast-enhancing brain tumors following surgeries aided by use of 5-ALA induced fluorescence guidance and use of an intraoperative ultra-low field MRI is higher compared to surgeries aided by 5-ALA induced fluorescene alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Malignant Neoplasm of Nervous System, Glioma, Glioblastoma, Metastasis
Keywords
primary brain tumor, malignant glioma, intraoperative MRI, 5-ALA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control arm
Arm Type
Other
Arm Description
5-ALA fluorescence guided surgery in patients with contrast enhancing tumors.
Arm Title
Interventional arm
Arm Type
Other
Arm Description
5-ALA fluorescence guided surgery with the additional use of an intraoperative MRI for resection control in patients with contrast enhancing tumors.
Intervention Type
Procedure
Intervention Name(s)
Interventional arm
Other Intervention Name(s)
5-ALA, 5-Aminolevulinic acid hydrochloride
Intervention Description
5-ALA fluorescence guided surgery with the additional use of an intraoperative MRI for resection control in patients with contrast enhancing tumors.
Intervention Type
Procedure
Intervention Name(s)
Control arm
Other Intervention Name(s)
5-ALA, 5-Aminolevulinic acid hydrochloride
Intervention Description
5-ALA fluorescence guided surgery in patients with contrast enhancing tumors.
Primary Outcome Measure Information:
Title
Extent of Resection
Description
The primary efficacy endpoint is the rate of complete resections according to early postoperative MRI.
Time Frame
Early postoperative MRI within 72 hrs
Secondary Outcome Measure Information:
Title
Volumetric extent of resection
Description
Secondary endpoint is the volumetric extent of resection as determined by direct comparison of preoperative and early postoperative tumor volumes.
Time Frame
Early postoperative MRI within 72hrs
Title
PFS 6
Description
Secondary endpoint is the rate of subjects with progression-free survival (PFS) 6 months after tumor resection
Time Frame
6 months following surgery
Title
PFS 12
Description
Secondary endpoint is the rate of subjects with progression-free survival (PFS) 12 months after tumor resection
Time Frame
12 months following surgery
Title
Quality of life
Description
Patient quality of life at 6 and 12 months following surgery is a secondary endpoint
Time Frame
6 months/12 months
Other Pre-specified Outcome Measures:
Title
NIHSS
Description
The change of NIHSS (The NIH Stroke Scale) score is an other pre-specified outcome measure
Time Frame
5 days following surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patient (> 18 years) able to give informed consent primary supratentorial intra-axial brain tumor exhibiting contrast enhancement suspected to be malignant glioma tumor must be deemed completely resectable by neurosurgeon diagnostic MRI Exclusion Criteria: patient unable or unwilling to give informed consent infratentorial tumor location tumor location in or near eloquent areas multifocal tumor existance of contraindications to undergo MRI examination previous surgical treatment for an intraaxial brain tumor
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Senft, MD PhD
Phone
069-6301
Ext
5939
Email
c.senft@med.uni-frankfurt.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Senft, MD PhD
Organizational Affiliation
Dept. of Neurosurgery, Johann Wolfgang Goethe University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Neurochirurgie Johann Wolfgang Goethe University
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60528
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Senft, MD PhD
Phone
069-6301
Ext
5939
Email
c.senft@med.uni-frankfurt.de

12. IPD Sharing Statement

Learn more about this trial

Intraoperative MRI and 5-ALA Guidance to Improve the Extent of Resection in Brain Tumor Surgery

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